Transcatheter Heart Valve Replacement Systems vs TAVR for Severe Aortic Stenosis: Comparing Outcomes

No significant difference in all-cause mortality were observed in patients undergoing interventions with transcatheter heart valve systems vs transcatheter aortic valve replacement for severe aortic stenosis.

No significant difference in all-cause mortality were observed in patients undergoing interventions with transcatheter heart valve (THV) systems vs transcatheter aortic valve replacement (TAVR) for severe aortic stenosis, according to results from a network meta-analysis published in the Canadian Journal of Cardiology.

Publication databases were curried through November 2019 for studies of patients with symptomatic severe aortic stenosis in which the safety and efficacy of surgical aortic valve replacement (SAVR) vs THV systems were compared. THV systems examined were balloon-expandable valve (BEV), self-expanding valve (SEV), and mechanically expandable valve (MEV). A total of 11 randomized controlled trials were included investigating outcomes in 10,300 patients (mean age, 79.9±7.4 years; 55.8%, men) with a minimum 30-day follow-up.

The analyzed studies included patients that were at high (n=6), intermediate (n=2), and low (n=3) surgical risk.

No significant difference were observed between THV systems and SAVR for short- or long-term survival or short-term disabling stroke.

For differences in short-term outcomes between treatments, BEV (risk ratio [RR], 0.33; 95% CI, 0.20-0.54) and SEV (RR, 0.52; 95% CI, 0.33-0.83) had a decreased risk for major or disabling bleeds when compared with SAVR. All THV systems had an elevated risk for major vascular complications when compared with SAVR: BSV (RR, 2.03; 95% CI, 1.23-3.34), SEV (RR, 2.68; 95% CI, 1.64-4.39), and MEV (RR, 3.55; 95% CI, 1.18-10.63). Risk for acute kidney injury was lower for BEV (RR, 0.37; 95% CI, 0.20-0.67) and SEV (RR, 0.46; 95% CI, 0.27-0.79) when compared with SAVR.

In the long term, disabling stroke was lower for MEV (hazard ratio [HR], 0.31; 95% CI, 0.12-0.77) and BEV (HR, 0.33; 95% CI, 0.14-0.76) when compared with SAVR. Need for a new permanent pacemaker was significantly lower for BEV (HR, 3.82; 95% CI, 1.83-7.97), SEV (HR, 1.85: 95% CI, 1.02- 3.36), and SAVR (HR, 5.23; 95% CI, 2.61-10.47) than for MEV. When compared with SAVR, BEV (RR, 4.01; 95% CI, 1.53-10.50) and SEV (RR, 18.35; 95% CI, 4.78-70.47) were associated with increased risk for moderate to severe paravalvular leak.

A major limitation of this study was the choice to include patients of differing surgical risks. The introduction of such heterogeneity to the data make these results difficult to interpret for a general patient population, however the low number of patients in each risk group made further stratification impossible.

“Although stroke occurs less frequently after TAVR compared with SAVR, stroke is a crucial complication of TAVR with devastating outcomes,” noted the study authors.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Ueyama H, Kuno T, Ando T, et al. Network meta-analysis of surgical aortic valve replacement and different transcatheter heart valve systems for symptomatic severe aortic stenosis. Can J Cardiol. 2020;S0828-282X(20)30193-8. doi:10.1016/j.cjca.2020.02.088